Randomized Study of Two Treatment Strategies With Ribavirin for Chronic Hepatitis E and Severe Acute Forms
Overview
- Phase
- Phase 4
- Intervention
- Ribavirin
- Conditions
- Hepatitis E
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Sustained virological response measured by HEV RNA
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of the study is to compare the efficacy, safety and recurrence rate of two therapeutic strategies with ribavirin in patients with chronic hepatitis E and severe acute hepatitis E: fixed duration of treatment for 12 weeks vs variable duration depending on the viremia within 4 weeks of the start of treatment (12 vs 24 weeks).
The purpose of the study is also improve the safety of treatment with Ribavirin by optimizing dose adjusted to renal function, plasma levels of drug and hemoglobin.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age equal or greater than 18 years.
- •To comply with any of the following diagnoses:
- •chronic Hepatitis E: HEV RNA detectable in patients with elevated transaminase levels for at least 6 months and / or HEV RNA detectable in two separated determinations by an interval of six months .
- •severe acute Hepatitis E: alanine aminotransferase (ALT) levels greater than 10 times the normal limit, with HEV RNA positive, and signs of acute liver injury (International normalized ratio(INR\> 1.5)); or with extrahepatic manifestations or liver failure in patients with previous liver disease.
- •Signed informed consent
Exclusion Criteria
- •Terminal illness with a expected life expectancy of less than 6 months
- •Patients with contraindications for treatment with Ribavirin:
- •pregnancy or lactation.
- •Severe hepatic impairment or decompensated cirrhosis.
- •hemoglobinopathies (thalassemia, sickle cell anemia).
- •history of severe pre-existing cardiac disease, including unstable heart disease.
Arms & Interventions
Group A
Patients will receive ribavirin during 12 weeks
Intervention: Ribavirin
Group B
Patients will receive: * ribavirin during 12 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is undetectable at week 4 after treatment start (adjust to renal function) * - ribavirin during 24 weeks if RNA (Ribonucleic acid) Hepatitis E virus (HEV) is detectable at week 4 after treatment start (adjust to renal function)
Intervention: Ribavirin
Outcomes
Primary Outcomes
Sustained virological response measured by HEV RNA
Time Frame: 48 weeks
HEV RNA undetectable at 48 weeks after end of treatment